WO2015007235A1 - Intradermal positioning apparatus for lumbar vertebra minimally invasive surgery - Google Patents
Intradermal positioning apparatus for lumbar vertebra minimally invasive surgery Download PDFInfo
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- WO2015007235A1 WO2015007235A1 PCT/CN2014/082478 CN2014082478W WO2015007235A1 WO 2015007235 A1 WO2015007235 A1 WO 2015007235A1 CN 2014082478 W CN2014082478 W CN 2014082478W WO 2015007235 A1 WO2015007235 A1 WO 2015007235A1
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- positioner
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- intradermal
- minimally invasive
- positioning device
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/846—Nails or pins, i.e. anchors without movable parts, holding by friction only, with or without structured surface
- A61B17/848—Kirschner wires, i.e. thin, long nails
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3472—Trocars; Puncturing needles for bones, e.g. intraosseus injections
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
- A61B2017/3445—Cannulas used as instrument channel for multiple instruments
Definitions
- the present invention belongs to the technical field of medical instruments, and in particular relates to an intradermal positioning device for minimally invasive surgery of the lumbar spine. Background technique
- the intradermal positioning device for minimally invasive surgery of the lumbar spine is composed of a positioner 1 and a Kirschner wire 2, and the positioner 1 is a columnar structure, and one end has a pointed structure for intraoperative insertion.
- the intradermal portion, the other end is a flat head, and is used for the extracutaneous portion; a plurality of hollow channels are arranged in parallel in the positioner 1, and the hollow channel is used for the Kirschner wire 2 for intraoperative positioning.
- the positioner 1 is made of an X-ray non-developing material (may be a polymer, wood, or the like which is not developed on the X-ray), and can be formed by stamping, molding, or Handmade.
- an X-ray non-developing material may be a polymer, wood, or the like which is not developed on the X-ray
- the Kirschner wire 2 is a conventional Kirschner wire commonly used in orthopedic surgery.
- the method for using the intradermal positioning device for minimally invasive surgery of the lumbar spine has the following specific steps: According to the pedicle position marked by the body surface, the fat and thinness of the patient and the head tilt angle of the vertebral body, a skin incision of 0.95-1.05 cm was cut at a distance of l-1.5 cm beside the surface of the pedicle screw of the body surface. After the stage is expanded, insert the positioner, then insert 3-4 pieces of Kirschner wire from each positioner, perform X-ray fluoroscopy of the positive side, select the appropriate K-wire for the positioning of the needle, and remove the remaining K-wires. Needle; if there is no suitable Kirschner wire, leave the K-wire needle closest to the desired position, then adjust the position by the positioner, and then select the appropriate K-wire for positioning.
- the present invention can achieve the effects of dozens of fluoroscopys by only 1-2 intraoperative fluoroscopy, and has the characteristics of accurate positioning, shortening operation time, and reducing radiation of medical personnel.
- FIG. 1 is a front structural view of the present invention.
- FIG. 2 is a side view showing the structure of the present invention.
- FIG. 3 is a schematic view of a cut in a desired surgical portion.
- FIG. 5 is a simulation diagram of the Kirschner needle driving into the positioner (position is appropriate).
- FIG. 6 is an effect diagram of a suitable position.
- FIG. 7 is a simulation diagram of the Kirschner needle driving into the positioner (inappropriate position).
- Figure 8 shows the effect of the position being unsatisfactory and the adjusted position is suitable.
- Embodiment 1 As shown in FIG. 1-2, wherein the inside of the locator 1 is divided into a pointed end, the outer part of the skin is divided into a flat head, and a plurality of hollow channels are provided, which are worn by the Kirschner wire 2 for intraoperative positioning.
- Figure 3-8 (this part is better described in conjunction with the figure).
- the pedicle position marked by the body surface the fatness of the patient and the tilt angle of the vertebral body, the position of the pedicle screw in the body surface is marked. Cut a skin incision around l-1.5cm and cut a lcm or so
- FIG. 5 remove the remaining Kirschner wires (Fig. 6). If there is no suitable K-wire, then the most close is left. The position of the Kirschner wire (Fig. 7), and then adjust the position by the intradermal positioning device and then select the appropriate Kirschner wire for positioning (Fig. 8).
- B 3-4 pieces of Kirschner wire are inserted into each intradermal positioning device to perform X-ray fluoroscopy of the positive side;
- C K-wires are placed at appropriate positions for piercing and positioning;
- E There is no suitable Kirschner wire, so the K-wire is the closest to the satisfactory position; F: Adjust the position by the intradermal positioning device and select the appropriate K-wire for positioning.
- Example 2 The inventors have conducted relevant clinical studies on the positioner. For 121 patients with lumbar disc herniation complicated with lumbar instability and thoracolumbar fractures, the traditional method was compared with the new method. It was found that the traditional method was used to implant double percutaneous pedicle screws in patients with single segmental disease. The positioning time is 15.12 ⁇ 4.69min, and the number of positioning times is 6.47 times. The new method using the positioner has a positioning time of 5.51 ⁇ 1.32 min and a positioning time of 2.45.
Abstract
An intradermal positioning apparatus for lumbar vertebra minimally invasive surgery consists of a positioning device (2) made of an X-ray transparent material and a plurality of kirschner wires (1). An intradermal part of the positioning device (2) is a sharp head, and an extradermal part of the positioning device is a flat head; a plurality of hollow channels is formed in the positioning device, and kirschner wires (1) used for positioning penetrate the hollow channels. The kirschner wires (1) are the commonly used kirschner wires in orthopedics surgery. The positioning device has the advantages of high positioning accuracy, short positioning time, less X-ray times, and low X-ray radiant quantity that a medical staff and a patient receive, thereby having popularization and application value in minimally invasive spine surgery.
Description
腰椎微创手术术中皮内定位装置 技术领域 Intradermal localization device for lumbar spine minimally invasive surgery
[0001] 本发明属医疗器械技术领域， 特别是涉及一种腰椎微创手术术中皮内 定位装置。 背景技术 [0001] The present invention belongs to the technical field of medical instruments, and in particular relates to an intradermal positioning device for minimally invasive surgery of the lumbar spine. Background technique
[0002] 脊柱微创手术的优势是创伤小， 出血少， 手术不需广泛剥离椎旁肌 肉， 对脊柱后方结构破坏极小， 不影响脊柱的稳定性。 而准确的术前术中定位对 于脊柱微创手术十分重要， 如果定位不准确， 就势必造成不必要的脊柱后方结构 的破坏， 从而增加损伤。 这在脊柱微创手术中表现的尤为明显， 如术中经皮椎弓 根螺钉的植入， 既往没有任何的定位装置， 只有通过反复的透视才能明确导针的 植入方向、 深度。 这种单纯凭借感觉的方法不够准确， 往往需要丰富的手术经 验， 再配合反复透视才能完成； 既增加手术时间， 又使医护人员及患者多次暴露 在 X线辐射下。 发明内容 [0002] The advantage of spinal minimally invasive surgery is that the trauma is small, the bleeding is less, the operation does not need to extensively exfoliate the paraspinal muscles, and the damage to the posterior structure of the spine is minimal, which does not affect the stability of the spine. Accurate preoperative intraoperative positioning is very important for minimally invasive surgery of the spine. If the positioning is not accurate, it will inevitably cause unnecessary destruction of the structure behind the spine, thus increasing the damage. This is particularly evident in minimally invasive surgery of the spine. For example, the implantation of a percutaneous pedicle screw does not have any positioning device. The direction and depth of the needle can be clearly determined by repeated perspective. This method of relying solely on sensation is not accurate enough, and often requires extensive surgical experience, which can be completed with repeated fluoroscopy; it increases the operation time and exposes the medical staff and patients to X-ray radiation multiple times. Summary of the invention
[0003] 为使脊柱微创手术术中的定位更加准确， 缩短手术时间， 减少医护人 员的辐射， 我们设计了专门用于腰椎微创手术术中皮内定位装置并应用于临床。 [0003] In order to make the positioning of spinal minimally invasive surgery more accurate, shorten the operation time, and reduce the radiation of medical staff, we designed a intradermal positioning device for lumbar minimally invasive surgery and applied it to the clinic.
[0004] 本发明提出的一种腰椎微创手术术中皮内定位装置， 由定位器 1和克 氏针 2组成， 定位器 1为柱状结构， 其一端为尖头结构， 用于术中插入皮内部分， 另一端为平头， 用于皮外部分； 定位器 1内平行分布有若干条空心通道， 所述空 心通道用于术中定位用的克氏针 2穿入。 [0004] The intradermal positioning device for minimally invasive surgery of the lumbar spine is composed of a positioner 1 and a Kirschner wire 2, and the positioner 1 is a columnar structure, and one end has a pointed structure for intraoperative insertion. The intradermal portion, the other end is a flat head, and is used for the extracutaneous portion; a plurality of hollow channels are arranged in parallel in the positioner 1, and the hollow channel is used for the Kirschner wire 2 for intraoperative positioning.
[0005] 本发明中， 所述定位器 1 采用 X线不显影材质 （可为高分子、 木材等 各种在 X线上不显影材质均可） ， 制作方法为可模具冲压， 一次成型， 或手工制 作。 [0005] In the present invention, the positioner 1 is made of an X-ray non-developing material (may be a polymer, wood, or the like which is not developed on the X-ray), and can be formed by stamping, molding, or Handmade.
[0006] 本发明中， 所述克氏针 2为骨科术中常用的普通克氏针。 In the present invention, the Kirschner wire 2 is a conventional Kirschner wire commonly used in orthopedic surgery.
[0007] 本发明提出的腰椎微创手术术中皮内定位装置的使用方法， 具体步骤 如下：
根据体表标记的椎弓根位置、 患者的胖瘦及椎体的头倾角度， 在体表椎弓根 螺钉标记位置旁开 l-1.5cm处切开一个 0.95-1.05cm的皮肤切口， 逐级扩张后插入定 位器， 然后再从每个定位器内打入 3-4枚克氏针， 进行正侧位的 X线透视， 选取合 适的克氏针用于穿剌定位， 拔除其余克氏针； 如无合适的克氏针， 则留下最为接 近满意位置的克氏针， 然后通过定位器调整位置， 再选择合适的克氏针用于定 位。 [0007] The method for using the intradermal positioning device for minimally invasive surgery of the lumbar spine according to the present invention has the following specific steps: According to the pedicle position marked by the body surface, the fat and thinness of the patient and the head tilt angle of the vertebral body, a skin incision of 0.95-1.05 cm was cut at a distance of l-1.5 cm beside the surface of the pedicle screw of the body surface. After the stage is expanded, insert the positioner, then insert 3-4 pieces of Kirschner wire from each positioner, perform X-ray fluoroscopy of the positive side, select the appropriate K-wire for the positioning of the needle, and remove the remaining K-wires. Needle; if there is no suitable Kirschner wire, leave the K-wire needle closest to the desired position, then adjust the position by the positioner, and then select the appropriate K-wire for positioning.
[0008] 本发明可仅仅通过 1-2次术中透视达到以往数十次透视的效果， 具有 定位准确、 缩短手术时间、 减少医护人员的辐射的特点。 附图说明 [0008] The present invention can achieve the effects of dozens of fluoroscopys by only 1-2 intraoperative fluoroscopy, and has the characteristics of accurate positioning, shortening operation time, and reducing radiation of medical personnel. DRAWINGS
[0009] 图 1为本发明正面结构图示。 1 is a front structural view of the present invention.
[0010] 图 2为本发明侧面结构图示。 2 is a side view showing the structure of the present invention.
[0011] 图 3为在所需手术部分切口示意图。 [0011] FIG. 3 is a schematic view of a cut in a desired surgical portion.
[0012] 图 4为本发明使用状态图。 4 is a use state diagram of the present invention.
[0013] 图 5为克氏针打入定位器的模拟图 （位置合适） 。 [0013] FIG. 5 is a simulation diagram of the Kirschner needle driving into the positioner (position is appropriate).
[0014] 图 6为位置合适的效果图 。 [0014] FIG. 6 is an effect diagram of a suitable position.
[0015] 图 7为克氏针打入定位器的模拟图 （位置不合适） 。 [0015] FIG. 7 is a simulation diagram of the Kirschner needle driving into the positioner (inappropriate position).
图 8为位置不理想， 调整后位置适合的效果图。 Figure 8 shows the effect of the position being unsatisfactory and the adjusted position is suitable.
[0016] 图中标号： 1为克氏针， 2为定位器。 具体实施方式 [0016] Reference numerals in the figure: 1 is a Kirschner wire, and 2 is a positioner. detailed description
[0017] 下面通过实施例进一步说明本发明。 [0017] The invention is further illustrated by the following examples.
[0018] 实施例 1 : 如图 1-2所示， 其中定位器 1皮内部分为尖头， 皮外部分为 平头， 另有数道空心通道， 为术中定位用的克氏针 2的穿入。 如图 3-图 8所示， （这 部分结合图来描述比较好)根据体表标记的椎弓根位置、 患者的胖瘦及椎体的头倾 角度， 在体表椎弓根螺钉标记位置旁开 l-1.5cm左右切开一个 lcm左右的皮肤切口 [0018] Embodiment 1: As shown in FIG. 1-2, wherein the inside of the locator 1 is divided into a pointed end, the outer part of the skin is divided into a flat head, and a plurality of hollow channels are provided, which are worn by the Kirschner wire 2 for intraoperative positioning. In. As shown in Figure 3-8, (this part is better described in conjunction with the figure). According to the pedicle position marked by the body surface, the fatness of the patient and the tilt angle of the vertebral body, the position of the pedicle screw in the body surface is marked. Cut a skin incision around l-1.5cm and cut a lcm or so
(如图 3 ) ， 逐级扩张后插入皮内定位装置 （图 4) ， 然后再从每个皮内定位装置 内打入 3-4枚克氏针， 进行正侧位的 X线透视， 选取合适的克氏针用于穿剌定位(Figure 3), insert the intradermal positioning device after expansion (Fig. 4), and then insert 3-4 K-wires from each intradermal positioning device to perform X-ray fluoroscopy of the lateral position. Suitable Kirschner wire for positioning
(图 5 ) ， 拔除其余克氏针 （图 6 ) 。 如均没有合适的克氏针， 则留下最为接近满
意位置的克氏针 （图 7 ) ， ， 然后通过皮内定位装置调整位置再选择合适的克氏 针用于定位 （图 8) 。 (Fig. 5), remove the remaining Kirschner wires (Fig. 6). If there is no suitable K-wire, then the most close is left. The position of the Kirschner wire (Fig. 7), and then adjust the position by the intradermal positioning device and then select the appropriate Kirschner wire for positioning (Fig. 8).
[0019] 本发明的工作流程如下： [0019] The workflow of the present invention is as follows:
A: 逐级扩张后插入皮内定位装置； A: Inserting the intradermal positioning device after stepwise expansion;
B: 每个皮内定位装置内打入 3-4枚克氏针， 进行正侧位的 X线透视； C: 选取位于合适位置的克氏针用于穿剌定位； B: 3-4 pieces of Kirschner wire are inserted into each intradermal positioning device to perform X-ray fluoroscopy of the positive side; C: K-wires are placed at appropriate positions for piercing and positioning;
D:图中红色标记为合适的克氏针； D: the red mark in the figure is a suitable K-wire;
E: 均没有合适的克氏针， 则留下最为接近满意位置的克氏针； F: 通过皮内定位装置调整位置再选择合适的克氏针用于定位。 E: There is no suitable Kirschner wire, so the K-wire is the closest to the satisfactory position; F: Adjust the position by the intradermal positioning device and select the appropriate K-wire for positioning.
[0020] 实施例 2: 发明人对定位器做过相关的临床研究。 对 121例腰椎间盘突 出症合并腰椎不稳患者及胸腰椎骨折患者， 使用传统方法与新型方法对比， 发现 使用传统方法在单一节段病变患者术中植入双枚经皮椎弓根螺钉前的定位时间为 15.12± 4.69min， 定位次数分别为 6.47次。 而使用定位器的新型方法定位时间为 5.51 ± 1.32min ， 定位次数为 2.45次。
Example 2: The inventors have conducted relevant clinical studies on the positioner. For 121 patients with lumbar disc herniation complicated with lumbar instability and thoracolumbar fractures, the traditional method was compared with the new method. It was found that the traditional method was used to implant double percutaneous pedicle screws in patients with single segmental disease. The positioning time is 15.12± 4.69min, and the number of positioning times is 6.47 times. The new method using the positioner has a positioning time of 5.51 ± 1.32 min and a positioning time of 2.45.
Claims
1. 一种腰椎微创手术术中皮内定位装置， 由定位器（1)和克氏针（2)组成， 其特征在于定位器（1)为柱状结构， 其一端为尖头结构， 用于术中插入皮内部 分， 另一端为平头， 用于皮外部分； 定位器（1)内平行分布有若干条空心通道， 所述空心通道用于术中定位用的克氏针 (2)穿入。 1. A intraoperative intradermal positioning device for minimally invasive surgery of the lumbar spine, comprising a positioner (1) and a Kirschner wire (2), characterized in that the positioner (1) is a columnar structure and one end is a pointed structure, The intradermal portion is inserted during the operation, and the other end is a flat head for the extracutaneous portion; a plurality of hollow channels are arranged in parallel in the positioner (1), and the hollow channel is used for the intra-operative positioning of the Kirschner wire (2) Penetrate.
2. 根据权利要求 1所述的腰椎微创手术术中皮内定位装置， 其特征在于所述 定位器 1采用 X线不显影材质， 制作方法为可模具冲压， 一次成型， 或手工制作。 2. The intraoperative intradermal positioning device for minimally invasive surgery of the lumbar spine according to claim 1, wherein the positioner 1 is made of X-ray non-developing material, and can be formed by die stamping, molding, or hand-made.
3. 根据权利要求 1所述的腰椎微创手术术中皮内定位装置， 其特征在于所述 克氏针 (2)为骨科术中常用的普通克氏针。 3. The intraoperative intradermal positioning device for minimally invasive surgery of the lumbar spine according to claim 1, wherein the Kirschner wire (2) is a common Kirschner wire commonly used in orthopedic surgery.
4. 一种如权利要求 1所述的腰椎微创手术术中皮内定位装置的使用方法， 其 特征在于具体步骤如下： 4. A method of using a intradermal positioning device for minimally invasive surgery of a lumbar spine according to claim 1, wherein the specific steps are as follows:
根据体表标记的椎弓根位置、 患者的胖瘦及椎体的头倾角度， 在体表椎弓根 螺钉标记位置旁开 1-1. 5cm处切开一个 0. 95-1. 05cm的皮肤切口， 逐级扩张后插入 定位器， 然后再从每个定位器内打入 3-4枚克氏针， 进行正侧位的 X线透视， 选取 合适的克氏针用于穿剌定位， 拔除其余克氏针； 如无合适的克氏针， 则留下最为 接近满意位置的克氏针， 然后通过定位器调整位置， 再选择合适的克氏针用于定 位。
5厘米的处。 The pedicle of the pedicle of the body surface, the fat and thinness of the patient's body and the slanting angle of the vertebral body, in the surface of the pedicle screw marked 1-1. 5cm cut open a 0. 95-1. 05cm The skin incision is inserted into the positioner after being expanded step by step, and then 3-4 K-wires are inserted from each positioner to perform X-ray fluoroscopy of the positive side, and a suitable K-wire is selected for the positioning of the needle. Remove the remaining K-wires; if there is no suitable K-wire, leave the K-wire that is closest to the desired position, then adjust the position by the positioner and select the appropriate K-wire for positioning.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310304204XA CN103356278A (en) | 2013-07-19 | 2013-07-19 | Intradermal positioning device for lumbar vertebra minimally invasive surgery |
| CN201310304204.X | 2013-07-19 |
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| WO2015007235A1 true WO2015007235A1 (en) | 2015-01-22 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103356278A (en) * | 2013-07-19 | 2013-10-23 | 贺石生 | Intradermal positioning device for lumbar vertebra minimally invasive surgery |
| CN104665917A (en) * | 2015-02-15 | 2015-06-03 | 陆爱清 | Intramedullary nail entry point regulator |
| CN104665918B (en) * | 2015-02-15 | 2017-08-25 | 陆爱清 | Guide pin entry point position developer |
| CN105167837A (en) * | 2015-08-10 | 2015-12-23 | 张英泽 | Aiming device for minimally invasive treatment of pubic ramus fracture |
| CN105411654B (en) * | 2016-01-21 | 2017-10-20 | 王洪伟 | A kind of vertebral pedicle puncture track guider |
| CN105963000A (en) * | 2016-06-03 | 2016-09-28 | 梧州市红十字会医院 | Thoracic lumbar puncture positioning device |
| CN107049374B (en) * | 2017-03-22 | 2018-06-22 | 中国人民解放军第四军医大学 | The auxiliary tool and device of a kind of minimal invasive lumbar surgery |
| CN107184268A (en) * | 2017-07-03 | 2017-09-22 | 宁波市第六医院 | Wrist scaphoid Kirschner wire guider and its application method |
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| CN202982255U (en) * | 2013-01-05 | 2013-06-12 | 袁健东 | Puncture positioning regulator for spinal endoscopic transforaminal operation |
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| US7601155B2 (en) * | 2003-05-20 | 2009-10-13 | Petersen Thomas D | Instruments and method for minimally invasive surgery for total hips |
| CN201147351Y (en) * | 2007-07-06 | 2008-11-12 | 刘小勇 | Auxiliary device of percutaneous vertebrae minimal invasive surgery |
| CN101623210B (en) * | 2009-08-05 | 2011-05-18 | 王德春 | Lumbar spondyloschisis forcing screw |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20110282348A1 (en) * | 2010-05-11 | 2011-11-17 | Gs Medical Co., Ltd. | Device for fixation of bone, and device set comprising the same |
| CN202446260U (en) * | 2011-12-26 | 2012-09-26 | 山东冠龙医疗用品有限公司 | Spinal surgery location device |
| CN202982255U (en) * | 2013-01-05 | 2013-06-12 | 袁健东 | Puncture positioning regulator for spinal endoscopic transforaminal operation |
| CN203042422U (en) * | 2013-01-31 | 2013-07-10 | 镐英杰 | Vertebral pedicle aiming device and aiming machine thereof |
| CN103356278A (en) * | 2013-07-19 | 2013-10-23 | 贺石生 | Intradermal positioning device for lumbar vertebra minimally invasive surgery |
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